Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive Potassium Hydroxide (KOH) using calcofluor. Ketoconazole 2% foam will be used to determine its effectiveness, safety and satisfaction when used to treat tinea versicolor.

To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor

To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor based on the occurrence of adverse events.

To assess treatment satisfaction as rated by patients

Study Design:

This will be a mono-centered, single arm, open-label pilot study. Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive KOH using calcofluor, will be enrolled at the University of Alabama at Birmingham. There will be 4 scheduled visits (baseline, week 1, week 2, and week 4). A target area will be identified and mycological and clinical assessments will be performed at this site as well as a global assessment of each subject. Ketoconazole 2% foam will be applied to all affected areas for 2 weeks with a follow-up visit at week 4. Skin scraping using a disposable #15 blade for calcofluor/potassium hydroxide (KOH) assessment and photographs of target lesions will be performed at baseline, week 1, week 2, and week 4. Photographs will be taken at baseline and at week 4 (only if KOH is positive). Body surface area estimation of disease will also be performed at each visit. Evaluation of scale, hyperpigmentation/erythema, and hypopigmentation using a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) of the target area will be performed at baseline, week 1, week 2, and week 4. A global assessment will be conducted at each visit using the same 4 point scale. Patient questionnaires will be administered at baseline and week 2 to assess symptoms and satisfaction with study medication.

If female, positive urine pregnancy test at screening (female patients of childbearing potential must be practicing a reliable method of birth control, not be planning a pregnancy, not be breast-feeding during the study)

Patients with a dermatologic condition in the region of the treatment site that in the investigator's opinion may interfere with the study results

Current diagnosis of immunocompromising conditions

Any medical or psychiatric condition that may interfere with treatment or compliance

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830388

Locations

United States, Alabama

UAB Dermatology

Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

Boni Elewski, MD

Investigators

Principal Investigator:

Boni E Elewski, MD

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:

Boni Elewski, MD, Principal Investigator, University of Alabama at Birmingham